A 10-year multicentre analysis of the frequency of sensitivity to common preservatives collected in 16 centres in 11 countries has shown stable but persisting high levels of sensitivity to formaldehyde and 5-chloro-2-methyl-4-isothiazolin-3-one + 2-methyl-4-isothiazolin-3-one (MCI/MI). It has also revealed a significant increase in the level of reactivity to methyldibromoglutaronitrile (MDBGN) from 0.7% in 1991 to 3.5% in 2000. The current high level of sensitivity to MDBGN requires an urgent safety re-evaluation and risk assessment update along with consideration of immediate lowering of use concentrations, especially in leave-on products.
The report reviews individual-related variables (age, sex, race, anatomical site), intra- and inter-individual variation (temporal, physical and mental activity, food and drugs), and environment-related variables (air convection, temperature). Technical variation, instrument validation including a standard reactive hyperemia experiment, and a standard operating procedure are discussed and included in the guidelines.
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